CellMax Life Launches Proprietary Blood Test for Immunotherapy Selection and Monitoring

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Test detects expression of PD-L1 protein in circulating tumor cells (CTCs) High sensitivity and low cost enable repeat testing to monitor patient response to immunotherapy throughout course of treatment

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CellMax Life, a leading cancer diagnostics company enabling early cancer detection with affordable non-invasive blood tests, announced today the U.S. launch of a blood test to detect the expression of PD-L1 – a key protein involved in suppressing the immune system – in circulating tumor cells (CTCs). Since immunotherapies work only on a minority of patients, identifying cancer patients expressing the PD-L1 protein in CTCs can help determine if they will benefit from the treatment, sparing significant costs and potential side effects.

A study on early and late stage lung cancer patients was recently completed, and the data will be shared at the upcoming American Association for Cancer Research (AACR) conference in Chicago on April 14 through 18. The test was able to capture CTCs for PD-L1 testing in blood in about 90 percent of tested patients. Conversely, tissue can be insufficient or unavailable for testing in 25 to 50 percent of advanced lung cancer patients. About 50 percent of the CTC tested patients were PD-L1 positive; this is consistent with previously reported PD-L1 positivity rates in clinical studies.

Dr. David Gandara, oncologist and director of the Thoracic Oncology Program at University of California, Davis, said: “PD-L1 testing by immunohistochemistry is a standard of care as a predictive biomarker for checkpoint immunotherapy. Blood-based testing offers three potential advantages. First, about 25 percent of patients have inadequate tumor tissue upfront to test for both molecular biomarkers and PD-L1. Second, PD-L1 is a dynamic biomarker, which can change over time, so using tumor from a prior biopsy may be misleading. PD-L1 can also be unevenly distributed in tissue, leading to a false negative and denying patients the opportunity to receive immunotherapy. Lastly, looking to the future, blood-based testing provides a means for repeat testing and timely monitoring, which would not be possible otherwise. A PD-L1 blood test can overcome current issues and would be an attractive alternative to tissue testing.”

“For the 1.7 million people diagnosed with cancer annually in the United States, and the 14.8 million people living with cancer there is no affordable, non-invasive and effective way to monitor patients for treatment response or cancer recurrence,” said Atul Sharan, CEO of CellMax Life. “With the invasiveness of tissue testing and high costs and limitations of existing DNA-based liquid biopsies, conducting repeat testing has been impractical, and often, impossible. CellMax CTC blood tests offer a solution to this major unmet need. We are also seeing a lot of interest from biopharmaceutical companies who want to partner with us to de-risk their clinical trials by using CTCs to monitor patients and identify non-responders to their drug early.”

CellMax Life also analyzes circulating tumor DNA (ctDNA) in the blood sample. The combination of DNA and CTC analysis makes the CellMax liquid biopsy the first and only blood test that includes all mutation classes recommended in the guidelines of the National Comprehensive Cancer Network (NCCN) for immunotherapy and targeted therapy selection in patients with advanced solid tumors.

About CellMax Life
CellMax Life is a leading cancer diagnostics company whose mission is to transform how cancer is diagnosed and managed with globally affordable non-invasive tests for early cancer detection and management. CellMax Life’s unique expertise in circulating tumor cells (CTC) and next generation sequencing (NGS) of DNA, as well as circulating tumor DNA (ctDNA) has enabled it to offer highly effective precision medicine solutions for healthy people, as well as patients diagnosed with cancer.

CellMax Life’s tests include CellMax-DNA Hereditary Cancer Risk Test, CellMax-CRC Colorectal Cancer Screening Test, CellMax-Prostate Cancer Test, CellMax-LBx Liquid Biopsy for immunotherapy and targeted therapy selection and CellMax-PanCa Monitoring Test. All clinical testing is performed at CLIA and CAP accredited laboratories in Sunnyvale, California and Taipei, Taiwan.

For additional information, please visit http://www.cellmaxlife.com.

Antenna Group
Michael Simmons (Media Contact)
CellMaxLife(at)antennagroup(dot)com
201-465-8030

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